ANDA 060575

DELCOR ASSET CORP

FDA Drug Application

Application #060575

Application Sponsors

ANDA 060575

DELCOR ASSET CORP

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

MYCOSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1965-02-09
LABELING; Labeling	SUPPL	8	AP	1998-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-09-11
LABELING; Labeling	SUPPL	12	AP	1993-03-16

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60575
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)